Preventing pressure injury in open‐heart surgical patients: A systematic review

Abstract Background Cardiac surgical patients are highly prone to developing surgery‐related Pressure injuries (PIs). Prevention of PIs is an important patient safety priority in healthcare settings and patients care. So the aim of this study is to detect the effectiveness of prevention strategies to decrease PIs prevalence and incidence in patients undergoing open heart surgery. Method We identified studies through Web of Science, Scopus, PubMed, Cochrane, and ProQuest databases from inception through September 2022 with restrictions on the English language. Cochrane RoB 2, JBI, and NIH checklist were carried out as critical appraisal Tools to investigate the studies risk of bias. Finally, 10 studies with a total sample No. 1348, which fulfilled eligibility criteria were included in final systematic review. Result Most common interventions investigated in included studies were addressing impairments skin care which included the use of multilayer silicone foam, Care bundle and multiple intervention programs, alternative head inflatable pads, pressure‐reducing foam mattresses, and electric bed frames as the effective PIs Prevention (PIP) strategies. While repositioning is one of the important causes mentioned in most PIP protocols, there was not adequate evidence to recommend any special turning regimens for PIP. Conclusion Given current evidence, multilayer silicone foam, Care bundle and multiple intervention programs, alternative inflatable head pads, pressure‐reducing foam mattresses, and electric bed frames are effective strategies to prevent pressure ulcers. Further investigations are needed to specify the cost‐effectiveness of mentioned strategies and RCTs to determine other PIP strategies such as repositioning and mobilization, nutritional supplementation, creams, and co‐interventions effects.


| INTRODUCTION
Pressure injuries (PIs) known as pressure ulcers, are one of the costliest medical problems and physically debilitating for patients. PIs are a common side effect of many high-acuity surgeries, and it has known as a major comorbid event due to cardiac surgery. 1 cardiac surgery patients are considered one of the most at-risk patient populations, with incidence rates reported as high as 24.06%. 2 PIs are potentially preventable but frequently occurring adverse events in hospitalized patients. 3 Prevention of PIs is an important patient safety priority in healthcare settings because PIs make a significant independent contribution to the excess patients' length of hospitalization. 4 In addition, patients must pay a significant additional cost for PIs treatment. 5 A systematic review found out Female sex, diabetes, advanced age, Duration of surgery and preoperative serum albumin level as the risk factors for developing PI in cardiac surgical patient that it needs to consider for PI prevention before and during the surgery. 2 A literature review also indicates that there is a variety of clinical studies on the use of dressings in the prevention of PI, such as hydrocolloids, foams, and films during surgery. 6 Some other studies proved that the incidence of PI can be reduced by using the multilayered silicone foam, because of its ability to reduce friction, pressure forces, and transferring shear away from critical spots. It can also reduce the costs. [6][7][8] The 2019 National Pressure Injury Advisory Panel (NPIAP, old NPUAP) guideline recommends using a pressure redistribution support surface on the operating table, such as a viscoelastic polymer pad, in patients undergoing surgery who are at the risk of developing pressure injuries; meanwhile, a soft silicone multilayered foam dressing is recommended in patients at risk of developing pressure injuries, but evidence for surgical patients is insufficient 9 and to our knowledge, there has been no systematic review conducted on the effectiveness of multicomponent PIs prevention programs, their components, and the strategies used to implement such programs in cardiac surgical patients. So we conducted a systematic review with the aim of detecting the effectiveness of PIs prevention strategies and interventions in reducing PIs prevalence and incidence in patients undergoing openheart surgery.

| Search strategy and information sources
We accomplished a systematic review, registered on PROSPERO (ID: CRD42022364468). This systematic review was performed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. 10 We formulated the research question according to the "PICO" format. Which interventions (single or bundled) are effective in preventing pressure injury in the open-heart surgical patients? Our review was conducted by reviewing the related literature in Web of Science, Scopus, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and ProQuest electronic databases without publication period restriction (up to September 2022) for English language clinical trials. "MeSH and non-MeSH keywords used to find" related studies were "Thoracic Surgery," "Coronary Artery Bypass," Embolectomy, "Heart Surgery," "Cardiac Surgery," "Cardiac Surgical Procedure," "Heart Transplantation," "Cardiac Valve Annuloplasty," "Pressure Ulcer," Bedsore, "Pressure Sore," "Decubitus Ulcer," "Pressure injury," "Prevention" and "Control"). Additional searches were conducted on conferences, registries, Google Scholar, and government websites. The reference lists of studies were also checked.

| Study selection process
Two researchers screened the abstracts of all retrieved studies to determine potentially relevant studies for this review. Then, the studies' full text was independently assessed by two researchers to verify the qualified articles to be included. Any disagreement was referred to third researcher if they haven't been settled by discussion.
The inclusion criteria were Randomized Controlled Trials (RCT), quasi-experimental and nonrandomized trials, pretest and posttest (before and after), and the studies that included the efficacy of preventive strategy on PI incidence in patients undergoing openheart surgerie-PI developed during surgery-(≥18 years old).
The exclusion criteria were the reviews, letters, editorials, and retrospective studies, lack of addressing the preventing PI, PI developed after surgery at critical care unit, being a duplicate, low quality, and high risk of bias according to critical appraisal tools.

| Quality assessment of the studies included
The bias risk assessment was carried out using Cochrane Risk-of-Bias tool for randomized trials (RoB 2), 11 Joanna Briggs Institute (JBI) Checklist for Quasi Experimental Appraisal tool, 12 and The National Institutes of Health (NIH) quality assessment tool for before-after (pre-post) study with no control group. 13 RoB 2 tool is structured into five domains for individually randomized trials 1 : bias arising from the randomization process 2 ; bias due to deviations from intended interventions 3 ; bias due to missing outcome data 4 ; bias in measurement of the outcome 5 ; bias in selection of the reported result. JBI checklist has five questions, which use to determine the quality of Quasi-experimental studies (nonrandomized) and NIH tool has 12 questions for quality assessment of before-after (pre-post) study without a control group.

| Data extraction
Two researchers extracted the data by using a pre-specified form.
The extracted data included the author's name, year of publication, study design, sample size, setting, intervention, result, conclusion, and so forth.

| Synthesis method
We summarized the included studies' characteristics, the components of the PIs prevention strategies, programs and intervention used, and the studies outcomes. Due to variations of strategies and interventions that were implemented, and the difference between outcome definitions and measures, we were unable to perform metaanalyses.

| Study selection
The PRISMA flow diagram 10 of the studies' selection process is shown in Figure 1. Three hundred and seventy-two studies were retrieved from electronic database searches. The title and abstract of 281 studies were reviewed after removing the duplicates. Two hundred and sixty-four studies were excluded and 17 articles were left to full-text review (five full-text were not retrieved). Three additional studies were found by searching the reference lists and citations of the 12 retrieved full-text. The reason for excluding five articles were described in Figure 1. The quality of the four studies was assessed by RoB, four studies by JBI tool, and two studies by NIH tool. No study was excluded based on the quality assessments, which finally left 10 studies with a total sample No. 1348, for the systematic review (Table 1).

| Included study characteristics
The 10 included studies' characterization are described in Table 1.
Regarding the PI preventive interventions, most of the featured studies focused on multilayer silicone foam. 16,18,20 Other studies were about implementation of donut-shaped cushions, 14 Care bundles including skin protection 17 multiple intervention programs including educating operating room and cardiovascular surgical intensive care unit staff on PIP strategies, 15 alternative inflatable head pads, 19 thermoactive viscoelastic foam pad, 21 foam mattresses and electric bed frames, 22 and low-air loss bed. 23 There was inadequate data about the effectiveness of other PI preventive strategies and interventions such as mobilization and repositioning, creams, and nutritional supplements.

| Main findings
Patient outcomes reported included PI incidence and prevalence and the binary outcome was assignment to intervention versus standard care and some other equipment or programs. In 6 of the 10 research  studies, the PI prevention interventions resulted in significant decreases in PI cumulative incidence [15][16][17][18][19]22 ; and a decrease in PI cumulative incidence with no statistical significance reported in four studies 14,20,21,23 ; two studies reported estimated reduced costs, with one reported savings of $78,660 after the implementation focused on Multiple intervention programs, 15 and another with a saving of $1,435,728 annually after the placement of a prophylactic anisotropic multilayer silicone foam dressing on the patient's sacrum before surgery. 18 The present systematic review identified four domains in terms of PI prevention among the included studies: multilayer silicone foam, Care bundle and multiple intervention programs, alternative inflatable head pads, pressure-reducing foam mattresses, and electric bed frames.

| Multilayer silicone foam
There are evidence that the use multilayered silicone foam can reduce the incidence of PI, in addition to reducing costs, because it has the ability to reduce pressure forces and friction, as well as transferring shear away from critical areas. [6][7][8] Among three included studies that assessed multilayer silicone foam as a PI preventive measure, two studies showed a statistically significant reduction in PI incidence rates.

| Care bundle multiple intervention programs
care bundles and multiple intervention programs are a set of evidence-based interventions that when performed together had a better and positive impact on patient outcomes when compared with individual interventions. 24 Two included studies with implementation multiple intervention program were effective in decreasing the incidence of PIs. 15,17

| Alternative inflatable head pad
An Alternating Pressure Air Mattresses (APAMs) could decrease the incidence of pressure lesions via repositioning to reduce the duration of direct pressure and shearing force. 25

| Pressure reducing foam mattress and electric bed frames
Mattresses, overlays, and cushions made of high-density or contoured foam or filled with beads, gel, fiber, air, or water that increase the area of contact between the patient and the support surface and thus reduce the pressure at the interface. 26 Pressure-reducing mattresses are often seen as central to any coherent PI prevention plan. 27  risk subjects recovering from major surgery were managed effectively without tissue damage. [23] Jesurum et al. 23  showed that multilayer silicone foam is an effective prophylactic intervention to reduce the incidence of perioperative deep-tissue PIs among cardiac surgery patients and it also is a cost-effective strategy used to prevent PI. 18 Cornish L. suggested that the use multi-layered silicone foam can reduce the incidence of PI, in addition to reducing costs. 6 A study that aimed to evaluate the clinical efficacy of using multi-layered silicone foam compared with polyurethane film in the prevention of PI in the intraoperative period of the spine showed some similar results. 29 22 Hampton study result also identified that patients experienced greater comfort on beds with the electric facility, produced less pressure sores, mobilized easily and pressure sore prevention costs could be reduced. 36

| LIMITATION
First, regarding difference between intervention and strategies used to PIP, we could not conduct a meta-analysis. Secondly, in defining intervention groups, we disregarded confounded co-interventions of included studies (e.g., repositioning) because these co-interventions were received equally by patients in both intervention and control group and they might have been influenced the effectiveness of main interventions. validation; writing-review and editing. Alireza Jalali Farahni: